Our Services
We provide comprehensive consulting services to help medical device and software companies navigate the complex regulatory landscape. Our expertise spans from initial concept to market approval and post-market surveillance.
Regulatory Affairs & Compliance
Specializing in MDR and MDCG guidance to ensure your software meets all necessary regulatory requirements in Germany and the EU.
Data Protection & GDPR
Ensuring GDPR compliance for your medical software, protecting sensitive patient data and building trust with your users.
AI in Medicine & AI-Act
Guidance on the upcoming AI-Act and its implications for AI-driven medical software, helping you navigate new legal landscapes.
Quality Management Systems
Implementation and maintenance of ISO 13485 compliant quality management systems tailored for medical device software.
Clinical Evaluation & CER
Comprehensive clinical evaluation reports and post-market clinical follow-up strategies for your medical software.
Software Validation & IEC 62304
Complete software lifecycle management according to IEC 62304, ensuring your development process meets regulatory standards.
Why Choose Zell Medical Consulting?
- Deep expertise in medical device regulations and software compliance
- Practical, hands-on approach tailored for startups and SMEs
- Direct partnership model with clear, actionable strategies
- Proven track record of successful market approvals
- Continuous support throughout your product lifecycle